Lawmakers lambaste FDA chief over fatal outbreak

Appearing under subpoena before a House panel, the co-owner of the compounding pharmacy linked to the meningitis outbreak that has killed more than 30 people took the Fifth Amendment and refused to answer questions Wednesday.

And in the first congressional hearing on the tainted-drug scandal, lawmakers clashed with Food and Drug Administration Commissioner Margaret Hamburg about why the crisis hadn’t been prevented — and whether her agency had, or would use, its powers to prevent another public health tragedy.

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Barry Cadden, a co-owner of the New England Compounding Center, took the Fifth Amendment and refused to answer a series of questions from Republicans and Democrats alike. So far, 32 people have died and 438 illnesses have been linked to three lots of injectable steroids made by NECC. The toll is likely to rise.

The hearing began on a bipartisan and personal note, as many members of the Energy and Commerce Subcommittee on Oversight and Investigations mentioned people from their districts or states who had been sickened or killed in the outbreak of fungal meningitis. The widow of one early victim testified about her loss and her bewilderment that injections meant to kill her husband’s back pain as he recovered from an accident had instead killed him.

But the questioning turned tough and skeptical when Hamburg said the agency needed clearer legal authority to regulate these compounding pharmacies, which act more and more like regular drug manufacturers but don’t fall under all the same regulatory requirements.

But lawmakers are divided about whether the agency needs more powers or needs to better use the powers it has. Some committee members lashed out, accusing the agency of failing to take action based on the documented problems at the NECC. They also said they were frustrated because the FDA had not yet handed over email, memos and other documents about the NECC case.

Hamburg said FDA’s authority is ambiguous and incomplete. She said the agency is not adequately empowered to address the “gray area” between traditional drug manufacturers and compounders who have gone beyond their traditional small-scale role of customizing prescriptions for individual patients and now make and ship large batches of drugs.

Hamburg argued that conflicting court rulings about FDA authority have led to different rules in force in different parts of the country. “The fact that we have unclear, contested and limited authorities, ambiguities in the law, a crazy quilt of legal authorities, has caused us to be very reactive,” she said.